Vaginal Vs Subling Misoprost Before Iud Insertion in Women With Previous CS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-23

Study Completion Date

2022-05-25

Brief Summary

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Insertion failures of intrauterine devices and cervical problems seem to occur more often among women who have never delivered vaginally. This trial will compare the effect of vaginal versus sublingual misoprostol prior to insertion of an intrauterine device in multiparous women delivered by CS.

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Detailed Description

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Intrauterine devices (IUDs) are widely used as reversible contraceptives. The current use of IUDs among reproductive-aged women ranges from 8 to 15% worldwide. Reported complications related to IUD insertion are 8.8% insertion failure, 2.8-11.5% cervical problems, 0.2% cervical perforation, 0.2% syncope and 5.8% expulsion. Insertion failures and cervical problems seem to occur more often among women who have never delivered vaginally.

Misoprostol is an inexpensive PGE1. Priming with misoprostol prior to hysteroscopy and dilatation and curettage (D\&C) in premenopausal women resulted in an increased cervical dilatation and rate of cervical laceration. Moreover, several studies have shown the benefit of misoprostol as a cervical ripening agent in nonpregnant women. The effect of misoprostol is dependent on the route of administration. Sublingual administration of misoprostol has been shown to be more effective also for cervical priming compared with oral administration and equally effective as vaginal administration.

larger studies on the effect of misoprostol for IUD insertion are lacking. Investigator therefore will conduct a trial aiming to compare the effect of vaginal versus sublingual misoprostol prior to insertion of an intrauterine device in multiparous women delivered by CS.

Conditions

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IUD Insertion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Misopristol

Group A: vaginal misoprostol will be taken Group B: sublingual misoprostol will be taken

Vaginal Versus Sublingual misoprostol

Intervention Type OTHER

Insertion failures of intra uterine devices and cervical problems seem to occur more often among women who have never delivered vaginally. Several studies have shown the benefit of misoprostol as a cervical ripening agent in nonpregnant women. This trial will compare the effect of vaginal versus sublingual misoprostol prior to insertion of an intrauterine device in multiparous women delivered by CS.

Interventions

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Vaginal Versus Sublingual misoprostol

Insertion failures of intra uterine devices and cervical problems seem to occur more often among women who have never delivered vaginally. Several studies have shown the benefit of misoprostol as a cervical ripening agent in nonpregnant women. This trial will compare the effect of vaginal versus sublingual misoprostol prior to insertion of an intrauterine device in multiparous women delivered by CS.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Women at the reproductive age group between 20-40 years Women who previously delivered by cesarean section. Women with BMI between 20- 30.

Exclusion Criteria

Women had a previous vaginal operations. Women with contraindications for misoprostol use (pregnancy, prostaglandin allergy) Women with a contraindication for IUCD insertion (e.g., less than sex weeks post-partum, gynecologic malignancy, uterine bleeding of undetermined origin, fibroids or other uterine abnormalities, active vaginitis or cervicitis, a history of PID or puerperal sepsis).

Women on anticoagulant therapy or having any coagulopathy. Women who refused to participate.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes